Description:
This study evaluates the immune response for patients affected by metastatic breast cancer
treated by everolimus
Title
- Brief Title: Immune Response for Patients With Metastatic Breast Cancer Treated by Everolimus
- Official Title: Study of the Immune Response T Anti-tumoral Cluster of Differentiation 4 (CD4) for Patients Treated for a Metastatic Breast Cancer by Everolimus Within the Framework of Its Marketing Authorization
Clinical Trial IDs
- ORG STUDY ID:
P/2012/159
- NCT ID:
NCT02854618
Conditions
Purpose
This study evaluates the immune response for patients affected by metastatic breast cancer
treated by everolimus
Trial Arms
Name | Type | Description | Interventions |
---|
Everolimus treatment | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- patients eligible for a treatment by everolimus in association with the exemestane
- Performance status of 0,1 or 2 according to the WHO
- Patients affected of a breast cancer advanced and\or metastatic HER2 negative
expressing the hormonal receptor RH +
- menopausal Patients
Exclusion Criteria:
- Psychiatric disease compromising the understanding of the information or the
realization of the study
- Vulnerable people according to the law (minors, adults under protection, private
persons of freedom)
- Histories of cancer in 5 years preceding the diagnosis (except breast cancer,
squamous-cell)
- Not menopausal women
- Unaffiliated people to the Social Security
- People being for the period of exclusion from another study
- Hypersensitivity in the active substance, in the other by-products of the rapamycin or
in one of the excipients.
- Symptomatic visceral achievement
- Legal incapacity or limited legal capacity
Maximum Eligible Age: | 85 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | level of the spontaneous anti-telomerase response |
Time Frame: | 12 months |
Safety Issue: | |
Description: | evaluation by Enzyme-Linked Immunospot (ELIspot) and by Enzyme-Linked Immunosorbent Assay (ELISA test) |
Secondary Outcome Measures
Measure: | T lymphocytes level |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | everolimus level in serum patients |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | angiopoietin 2 level |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | CD138 level |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | ps6K expression |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Merlin expression |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | neuropilin 2 expression |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | quality of life |
Time Frame: | 12 months |
Safety Issue: | |
Description: | EUROQOL EQ-5D, EORTC QLQ-C30 and BR 23 |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Centre Hospitalier Universitaire de Besancon |
Last Updated
February 1, 2021